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Are the New FDA Warning Letters Signaling Treatment of Hemp Extracts as Over the Counter Monographs?

The FDA issued two new warning letters on March 22, 2021. Previous rounds of warning letters have focused on whether the companies have made statements that would make the product a drug. These have focused on such things as (1) whether the company has made claims regarding alleviating a condition or disease (such as pain, cancer, epilepsy, etc.) and the method of delivery (transdermal, sublingual, rectal, etc.). The more egregious the claims being made, the more likely the company was to draw a warning letter. The most recent infamous example is that of Curaleaf, which drew a warning letter for a variety of claims made regarding CBD.  These tend to come out of the FDA’s Center for Drug Evaluation and Research (CDER) or the Division of Human and Animal Food Operations. Recent letters have also seen the involvement of other federal agencies, including the Federal Trade Commission.

The latest warning letters were issued against four companies. Two of the warning letters fell under business as usual, focusing on claims made regarding the Novel Coronavirus (COVID-19) and claims that fall under what could be considered the FDA’s usual enforcement priorities. However, two of the warning letters gave new insight as to where the industry may be headed. The warning letters issued to Honest Globe, Inc. and BioLyte Laboratories, LLC did not come out of CDER, but rather from the Division of Pharmaceutical Quality Operations. This division is responsible for enforcement of Good Manufacturing Practices within the pharmaceutical and over-the-counter (“OTC”) drug industries.

These letters are significant for two reasons. First, the letters are replete with discussions of the products as OTCs. Previously, the FDA has not made a distinction regarding unapproved new drugs and unapproved OTCs. Prior to this round of warning letters, the conventional wisdom was the the FDA would eventually classify hemp extracts and derivatives as a “New Dietary Ingredient”, or “NDI”. This would place the product strictly within the supplement category. In addition, House Resolution 841 was introduced February 4, 2021. The bill, if passed, would classify hemp and hemp extracts as an NDI for use in supplements:

Beginning on the date that is 90 days after the date of enactment of this Act, notwithstanding section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(3)(B)), hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp shall be lawful for use under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as a dietary ingredient in a dietary supplement, provided that such dietary supplement complies with:

  1. the requirements for a dietary supplement which contains a new dietary ingredient in section 413 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b); and
  2. all other applicable requirements for a dietary supplement in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).

The bill, which has bipartisan support (a rare thing in this day and age), is currently sitting at the House Committee on Energy and Commerce. Seriously, write your representatives on this one!

So, this OTC language within the FDA is possibly a signal that hemp and its extracts will no longer be the province of dietary supplements, but may be headed for OTC status. If this occurs, a slew of requirements will be placed on manufacturers of hemp products putting them out of reach for most companies. An overview of the process for OTC certification can be found here. While companies can assist with the process, the requirements are far more onerous than the supplement designation. Should you still be following GMP even if you are a supplement? Of course. But the additional requirements of OTC monographs are, in our opinion, a step too far for the industry.

The second significant aspect to these warning letters, in addition to their reference to OTC monographs, are the focus on GMP principles. These are stepping away from the usual warning letters you would see based strictly on the marketing programs and labeling, and instead are focusing on how to bring products to market.

Without knowing more about the companies at issue, it is hard to say whether these were fairly decent companies that simply were used as an example of where the FDA wants the industry to be headed, or whether there were other factors at play that made the FDA want to step in. Things such as very poor manufacturing processes could lead to a letter like this, but there is simply not enough information at hand to make the determination as to what triggered these letters.

Everyone in the industry is watching with bated breath to see whether the FDA is going to continue pushing the OTC narrative, or whether it will continue to be business as usual, with the standard set of enforcement priorities.

At this point, only one thing is certain, and that is uncertainty.

Justin WalshJustin Walsh

Justin Walsh

Justin P. Walsh is a senior cannabis business lawyer at Gleam Law’s Seattle headquarters (www.gleamlaw.com), where he represents clients in a myriad of civil matters – including legal marijuana, hemp, and CBD businesses. He has received recognition for his successful representation of complex business litigation cases, as well as personal injury, medical malpractice, class action, and intellectual property cases. His practice extends to copyright and trademark matters, Consumer Protection Act, and CAN-SPAM. In addition to heading Gleam Law’s litigation department, Justin also handles matters of regulatory compliance surrounding hemp and CBD – including FDA labeling compliance, a topic Justin regularly speaks on nationally.

Currently, Justin serves as a Pro Tem Judge in Washington, and is an adjunct professor teaching a class on cannabis law at Seattle University School of Law. Justin is admitted to practice in Washington and Alaska, as well as the Washington Supreme Court, the Federal District Courts for the Western and Eastern District of Washington, and the Ninth Circuit Court of Appeals. Justin can be reached at [email protected] if you have questions related to his areas of expertise.

This Post Has One Comment
  1. I’m not sure you should get too excited about those warning letters. The one to Honest Globe seems to be more of a reprimand of the company for suggesting that they are selling an approved OTC product. I don’t see the FDA using “OTC” in reference to their product, but rather in several explanations of why it doesn’t qualify as the OTC they are advertising it as.

    As for the letter to BioLyte, this one addresses several products, one of which is a colloidal silver preparation that is marketed as OTC. As far as I can see, the FDA never uses the term “OTC” in reference to their CBD product and actually states that it does not qualify [as OTC] under section 505G(a)(1) or (2).

    The problem seems to be that, because of the claims being made by the respective manufacturers, the CBD products in question are being sold as non-prescription drugs, implying that they are therefore being sold as OTC. The FDA simply appears to be telling these companies that their products can not be sold as OTC medications because they have not been approved as such and do not qualify for exemptions. The non-OTC clarifications are being offered in response to the language used by the manufacturers, not as any novel classification by the FDA.

    Seems to me the FDA is maintaining the status quo.

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